Method and apparatus for sternal closure

ABSTRACT

A method and apparatus for securing a fractured or sectioned sternum in a patient&#39;s body is disclosed. The apparatus can include an attachment member and an adjustable flexible member construct. The attachment member can have a flexible member holder. The adjustable flexible member construct can have first and second ends and a body defining at least one passage portion. The first and second ends can be passed into and through the at least one passage portion via first and second openings associated with the at least one passage portion of the adjustable flexible member construct to form a pair of loops. The attachment member can be configured to be coupled to at least one of the formed pair of loops. The adjustable flexible member construct can be positioned about the sternum and can be reduced to compress the fractured or sectioned sternum.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/094,311, filed Dec. 2, 2013, now U.S. Pat. No. 9,642,661 which issuedon May 9, 2017, which application is a divisional of U.S. patentapplication Ser. No. 12/938,902 filed on Nov. 3, 2010, now U.S. Pat. No.8,597,327 which issued on Dec. 3, 2013, which is a continuation-in-partof U.S. patent application Ser. No. 12/915,962 filed on Oct. 29, 2010,now U.S. Pat. No. 8,562,647 which issued on Oct. 22, 2013, which is acontinuation-in-part of U.S. patent application Ser. No. 12/719,337filed on Mar. 8, 2010, now U.S. Pat. No. 9,078,644 which issued on Jul.14, 2015, which is a continuation-in-part of U.S. patent applicationSer. No. 12/489,168 filed on Jun. 22, 2009, now U.S. Pat. No. 8,361,113issued on Jan. 29, 2013, which is a continuation-in-part of U.S. patentapplication Ser. No. 12/474,802 filed on May 29, 2009, now U.S. Pat. No.8,088,130 issued on Jan. 3, 2012, which is a continuation-in-part of (a)U.S. patent application Ser. No. 12/196,405 filed on Aug. 22, 2008, nowU.S. Pat. No. 8,128,658 issued on Mar. 6, 2012; (b) U.S. patentapplication Ser. No. 12/196,407 filed on Aug. 22, 2008, now U.S. Pat.No. 8,137,382 issued on Mar. 20, 2012; (c) U.S. patent application Ser.No. 12/196,410 filed on Aug. 22, 2008, now U.S. Pat. No. 8,118,836issued on Feb. 21, 2012; and (d) a continuation-in-part of U.S. patentapplication Ser. No. 11/541,506 filed on Sep. 29, 2006, which is nowU.S. Pat. No. 7,601,165 issued on Oct. 13, 2009.

U.S. patent application Ser. No. 14/094,311, filed Dec. 2.2013, now U.S.Pat. No. 9,642,661 which issued on May 9, 2017 is a continuation-in-partof U.S. patent application Ser. No. 13/645,964 filed on Oct. 5, 2012,now U.S. Pat. No. 9,504,460 which issued on Nov. 29, 2016, which is adivisional of U.S. patent application Ser. No. 12/570,854 filed on Sep.30, 2009, which is now U.S. Pat. No. 8,303,604 issued on Nov. 6, 2012,which is a continuation-in-part of U.S. patent application Ser. No.12/014,399 filed on Jan. 15, 2008, which is now U.S. Pat. No. 7,909,851issued on Mar. 22, 2011, which is a continuation-in-part of U.S. patentapplication Ser. No. 11/347,661 filed on Feb. 3, 2006, which is now U.S.Pat. No. 7,749,250 issued on Jul. 6, 2010.

U.S. patent application Ser. No. 14/094,311, filed Dec. 2, 2013, nowU.S. Pat. No. 9,642,661 which issued on May 9, 2017 is acontinuation-in-part of U.S. patent application Ser. No. 13/587,374filed on Aug. 16, 2012, now U.S. Pat. No. 8,777,956 which issued on Jul.15, 2014, which is a divisional of U.S. patent application Ser. No.12/029,861 filed on Feb. 12, 2008, which is now U.S. Pat. No. 8,251,998issued on Aug. 28, 2012, which is a continuation-in-part of U.S. patentapplication Ser. No. 11/504,882 filed on Aug. 16, 2006, now U.S. Pat.No. 8,998,949 which issued Apr. 7, 2015, which is a continuation-in-partof U.S. patent application Ser. No. 11/408,282 filed on Apr. 20, 2006,and now abandoned.

U.S. patent application Ser. No. 14/094,311, filed Dec. 2, 2013, nowU.S. Pat. No. 9,642,661 which issued on May 9, 2017 is acontinuation-in-part of U.S. patent application Ser. No. 12/702,067filed on Feb. 8, 2010, now U.S. Pat. No. 8,672,968 which issued on Mar.18, 2014, which is a continuation of U.S. patent application Ser. No.11/541,505 filed on Sep. 29, 2006 and is now U.S. Pat. No. 7,658,751issued on Feb. 9, 2010.

U.S. patent application Ser. No. 14/094,311, filed Dec. 2, 2013, nowU.S. Pat. No. 9,642,661 which issued on May 9, 2017 is acontinuation-in-part of U.S. patent application Ser. No. 13/098,927filed on May 2, 2011, now U.S. Pat. No. 8,652,171 which issued as Feb.18, 2014, which is a continuation-in-part of U.S. patent applicationSer. No. 12/196,398 filed Aug. 22, 2008, which is now U.S. Pat. No.7,959,650 issued on Jun. 14, 2011, which is a continuation-in-part ofU.S. patent application Ser. No. 11/784,821 filed Apr. 10, 2007, nowU.S. Pat. No. 9,017,381 which issued Apr. 28, 2015.

The disclosures of all of the above applications are incorporated byreference herein.

FIELD

The present disclosure relates generally to methods and arrangements forsecuring a fractured or sectioned bone, and more particularly to methodsand arrangements for sternal closure.

BACKGROUND

The statements in this section merely provide background informationrelated to the present disclosure and may not constitute prior art.

After trauma or surgical intervention, there may be a need to fix bonefragments or portions together to immobilize the fragments and permithealing. Compressive force can be applied to the bone fragments byencircling the bone fragments or bridging the fragments together acrossa broken, sectioned (cut) or otherwise compromised portion of the bone.The compressive forces should be applied such that upon ingrowth of newbone, the fragments will heal together and restore strength to the siteof trauma or surgical intervention.

Accordingly, there is a need for apparatus and methods to applycompressive force to a bone across a fracture or section (cut) tomaintain alignment and assist healing. Further, there is a need forapparatus and methods that are easy to use intraoperatively toaccommodate various bone sizes or shapes, or locations of bone fracturesor sections.

SUMMARY

This section provides a general summary of the disclosure, and is not acomprehensive disclosure of its full scope or all of its features.

In one aspect, an apparatus for securing a fractured or sectioned bonein a patient's body is provided. The apparatus can include an attachmentmember and an adjustable flexible member construct. The attachmentmember can have a flexible member holder. The adjustable flexible memberconstruct can have a body extending from a first end to a second end anddefining at least one passage portion. The first and second ends can bepassed into and through the at least one passage portion via at leastfirst and second openings associated with the at least one passageportion of the adjustable flexible member construct to form a pair ofloops. The attachment member can be configured to be coupled to at leastone of the formed pair of loops.

In another aspect, a method is provided for securing a fractured orsectioned sternum in a patient's body. The method can include forming anadjustable flexible member construct, which can include providing aflexible member having first and second ends and a body defining firstand second passage portions spaced apart from each other by a firstportion of the flexible member. The first end can be passed into andthrough the second passage portion and then into and through the firstpassage portion to form a first loop. The second end can be passed intoand through the first passage portion in an opposite direction as thefirst end and then into and through the second passage portion in anopposite direction as the first end to form a second loop. An attachmentmember can be coupled to the first and second loops. The fractured orsectioned sternum can be encircled by at least partially wrapping theformed adjustable flexible member construct about the sternum. The firstportion of the flexible member construct opposite the loops can becoupled to the attachment member. The adjustable flexible memberconstruct can be reduced to compress the fractured or sectioned sternum.

In yet another aspect, a method is provided for securing a fractured orsectioned sternum in a patient's body. The method can include providingan adjustable flexible member construct and positioning the adjustableflexible member construct across a fracture or section of the fracturedor sectioned sternum. The adjustable flexible member construct can havefirst and second ends and a body defining at least one passage portiontherebetween. The first and second ends can be passed into and throughthe at least one passage portion via at least first and second aperturesassociated with the at least one passage portion of the adjustableflexible member construct to form a pair of loops. A fixationarrangement can be provided and the pair of loops can be coupled to thefixation arrangement. The adjustable flexible member construct can bereduced to a reduced position to compress the fractured or sectionedsternum by applying tension to the first and second ends of theadjustable flexible member construct and thereby reducing the size ofthe pair of loops. The adjustable flexible member construct can beautomatically maintained in the reduced position.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The present teachings will become more fully understood from thedetailed description, the appended claims and the following drawings.The drawings are for illustrative purposes only and are not intended tolimit the scope of the present disclosure.

FIG. 1 depicts an adjustable flexible member construct according to thepresent teachings;

FIGS. 1A and 1B depict an exemplary method of assembling the adjustableflexible construct of FIG. 1 according to the present teachings;

FIG. 2 depicts an exemplary assembly configuration of the flexiblemember construct of FIG. 1 having an attachment member and an insertionmember according to the present teachings;

FIG. 2A depicts a side view of the attachment member of FIG. 2 accordingto the present teachings;

FIGS. 3, 3A and 3B depict alternative flexible member constructsaccording to the present teachings;

FIGS. 4 and 5 depict exemplary views of the adjustable flexible memberconstruct of FIG. 1 in a surgical procedure for sternal closureaccording to the present teachings;

FIGS. 6-9 depict views of exemplary alternative attachment membersassociated with one or more of the adjustable flexible member constructsaccording to the present teachings;

FIGS. 10 and 11 depict views of the attachment members of FIGS. 6-9 inexemplary configurations for use in a sternal closure procedureaccording to the present teachings;

FIG. 12 depicts a view of an exemplary use of the flexible memberconstruct of FIG. 3A in a surgical method for sternal closure accordingto the present teachings;

FIG. 13 depicts an exemplary alternative attachment member according tothe present teachings;

FIG. 14 depicts exemplary configurations of the attachment member ofFIG. 13 associated with various adjustable flexible member constructsaccording to the present teachings;

FIG. 15 depicts an exemplary surgical method for sternal closureaccording to the present teachings; and

FIG. 16 depicts an exemplary surgical method for sternal closureaccording to the present teachings.

DETAILED DESCRIPTION

The following description is merely exemplary in nature and is in no wayintended to limit the present disclosure, its application, or uses. Itshould be understood that throughout the drawings, correspondingreference numerals indicate like or corresponding parts and features.While the disclosure relates to apparatus and associated methods forsternal closure, the apparatus and methods of the present teachings canbe used in connection with various other fracture fixation methodsand/or procedures.

Referring to FIG. 1, an adjustable flexible member construct 10 isprovided according to various aspects of the present teachings. Theadjustable flexible member construct 10 can be fashioned from a flexiblemember 14 made of any biocompatible material including, but not limitedto, non-resorbable polymers, such as polyethylene or polyester,resorbable polymers, and various combinations thereof. In variousaspects, the adjustable flexible member construct 10 can include ahollow material or core to allow for appropriate tensioning, as will bediscussed herein. In various aspects, the adjustable flexible memberconstruct 10 can be a suture. In such aspects, the suture can be hollowor a braided or a multiple-filament braided suture structure having ahollow core. In various aspects, the suture can be resorbable. Invarious aspects, the adjustable flexible member construct 10 can definea substantially tubular hollow shape.

The adjustable flexible member construct 10 can include a first end 18,a first formed passage portion 22, a second end 26, a second formedpassage portion 30, and a fixed length loop portion 34 connecting thefirst and second passage portions 22, 30, as shown in FIG. 1. In oneexemplary aspect, flexible member construct 10 can include an elongatedbody 32 having an exterior surface and an interior surface defining anelongated passage between the first and second ends 18, 26. The body 32can define the first and second passage portions 22, 30 and the fixedlength portion 34 therebetween. Passage portions 22, 30 can each includefirst apertures 38, 42 positioned proximate one end thereof, and secondapertures 46, 50 positioned proximate a second opposite end thereof. Thepassage portions 22, 30 can be formed to have a larger width or diameterthan remaining portions of flexible member 14, as shown for example inFIG. 1. Alternatively, the passage portions 22,30 can be formedinitially to have the same width or diameter as the remaining portionsof flexible member 14, later expanding in diameter during theconstruction process. In various aspects, the first and second apertures38, 42, 46, 50 can be formed during a braiding process of flexiblemember 14 as loose portions between pairs of fibers defining flexiblemember 14, or can be formed during the construction process.Alternatively, the first and second ends can be pushed betweenindividual fibers of the braided flexible member 14, as will bediscussed herein.

To form the adjustable flexible member construct 10, first end 18 can bepassed through second passage portion 30 via first and second apertures42, 50, as generally shown in FIGS. 1A and 1B. In a similar manner,second end 26 can be passed through the first passage portion 22 via thefirst and second apertures 38, 46, as also shown in FIGS. 1A and 1B.Subsequently, as shown in FIG. 1B with reference to FIG. 1, first end 18can be passed through the first passage portion 22 via second and firstapertures 46 and 38, respectively. First end 18 can follow a path thatis opposite in direction to a path followed by a portion 54 of theflexible member 14 that has already passed through first passage portion22 while following second end 26 through first and second apertures 38and 46. Similarly, second end 26 can be passed through the secondpassage portion 30 via second and first apertures 50 and 42,respectively. First end 26 can follow a path that is opposite indirection to a path followed by a portion 58 of the flexible member 14that has already passed through second passage portion 30 whilefollowing first end 18 through first and second apertures 42 and 50.This results in portions 62, 64 of flexible member 14 being positionedparallel or substantially parallel to portions 54, 58 in passageportions 22, 30. Passing the first and second ends 18, 26 though passageportions 22, 30 as discussed above forms adjustable loops 66, 70, asshown in FIG. 1. The first and second ends can be passed through thesame apertures in each passage portion 22, 30 or, alternatively, throughseparate apertures in each passage portion 22, 30.

The adjustable flexible member construct 10 can thus provide a doubleadjustable loop configuration via loops 66, 70 while also providingportion 34, which can have a fixed length between the passage portions22, 30. As will be discussed in greater detail herein, thisconfiguration can be used, for example, to couple an attachment memberto loops 66, 70 and couple fixed length portion 34 to either theattachment member or another device. In this manner, the amount offriction developed within the first and second passage portions 22, 30relative to and among portions 54, 58, 62 and 64 during adjustment ofadjustable loops 66, 70 is reduced as compared to that which would occurif the attachment member were coupled to the passage portion when theloops are being adjusted or reduced in size under tension.

With additional reference to FIGS. 2 and 2A, adjustable flexible memberconstruct 10 is shown in an exemplary assembly configuration 76 havingan attachment member 80 coupled to a first side 84 of loops 66, 70opposite a second side 88 facing fixed length portion 34. Attachmentmember 80 can include a generally T-shaped configuration having a firststem portion 92 defining an aperture 94 for receipt of loops 66, 70therein at one end, and a transversely extending cross portion 96 at asecond opposite end. Transversely extending portion 96 can includeopposed lateral ends 104 that include arcuate or curled portions 108, asshown in FIG. 2A. In various aspects, attachment member 80 can be usedto secure a flexible member loop thereto by placing the loop over firstportion 92 and under arcuate portions 108, as shown for example in FIG.4.

The assembly configuration 76 can also include an optional grab memberor handle 116 and a passing or needle member 118. Handle 116 can be usedto aid the surgeon in easily pulling ends 18, 26 of construct 10 toreduce the size of loops 66, 70, as will be discussed in greater detailbelow. Handle 116 can include a first pair of apertures 120 positionedat opposed ends 124 of handle 116, as shown in FIG. 2. The first andsecond ends 18, 26 can be passed or routed through apertures 120 andthen through a central aperture 128, where ends 18, 26 can be secured tohandle 116 by various methods, including a knot 132, as also shown inFIG. 2. The surgeon can use handle 116 to apply simultaneous tension toends 18, 26, which can thereby evenly reduce or adjust loops 66, 70 to adesired size or tension.

Operation of the adjustable flexible member construct 10 will now bedescribed in greater detail with reference to an exemplary configurationwhere adjustable flexible member construct 10 is wrapped around orencircles a bone, such as a sternum, and fixed loop 34 is connected toattachment member 80, as shown for example in FIG. 4. It should beappreciated, however, that construct 10 can be used in variousattachment configurations, other than the example discussed above,wherein tension is applied to construct 10 via fixed loop 34 andattachment member 80 in connection with reducing or adjusting the sizeof loops 66, 70.

Upon applying tension to ends 18, 26, with or without handle 116, theloops 66, 70 can be reduced to a desired size and/or placed in a desiredtension by causing translation of ends 18, 26 relative to passageportions 22, 30. Tension in fixed length loop portion 34 combined withthe tension in adjustable loops 66, 70 can cause the body 32 of flexiblemember 14 defining the passage portions 22, 30 to constrict about theportions 54, 58 and 62, 64 of flexible member 14 passed therethrough.This constriction can reduce a width or diameter of each of the passageportions 22, 30, thereby forming a mechanical interface between exteriorsurfaces of the passed through portions of flexible member 14 andinterior surfaces of the passage portions 22, 30. The static frictionbetween the interior and exterior surfaces at the mechanical interfaceformed as a result of the constriction can prevent relative movement ofportions 54, 58, and 62, 64 relative to passages 22, 30 and henceprevent relaxation of the tension in construct 10, thereby preventing anincrease in the size of loops 66, 70. Thus, adjustable flexible memberconstruct 10 provides for “automatically” locking loops 66, 70 in areduced length or size under tension without requiring a knot.

Flexible member construct 10 can be provided in various sizes toaccommodate differently sized bones, such as sternums, in differentpatients. In one exemplary configuration, fixed loop portion 34 can beprovided in various sizes or lengths. Flexible member construct 10 canalso be provided with flexible member 14 having various diameters, suchas 30 thousandths of an inch or 37-40 thousandths of an inch. In oneexemplary configuration, the 30 thousandths diameter flexible member 14can be used, for example, where construct 10 is routed or passed throughholes drilled in the bone so that flexible member 14 can be more easilymanipulated during such routing. The larger 37-40 thousandths diameterflexible member 14 can be used, for example, where the construct 10 iswrapped around the sternum, as will be discussed herein. Forming theconstruct 10, as well as other constructs discussed herein, with alarger diameter flexible member provides more surface area of thetensioned flexible member to engage the sternum or other bone, and thusdistribute the compressive load over a greater area of the bone.

With additional reference to FIG. 3, and FIG. 3A, an exemplaryalternative adjustable flexible member construct 150 is shown. Construct150 can include a hollow flexible member 154 having a first end 158 anda second end 162, and can include a body 164 that defines a longitudinalpassage portion 168 therein between first and second ends 158, 162, asshown in FIG. 3. The passage portion 168 can define a pair of apertures172, 176 at opposed ends thereof, similar to apertures 38, 46 discussedabove. To form construct 150, the first end 158 can be passed throughaperture 172 and passage portion 168 and out aperture 176 such that aportion 180 of flexible member 154 following first end 158 extendsthrough passage portion 168. In a similar manner, second end 162 can bepassed through aperture 176 and passage portion 168 and out aperture 172such that a portion 184 of flexible member 154 following second end 162also extends through passage portion 168. This configuration forms twoloops 188 and 188′, as shown in FIG. 3. It should be appreciated thateach of the first and second ends 158, 162 can alternatively be pushedthrough a respective space defined between adjacent individual fibers ofthe braided flexible member 14 such that the respective spaces definedbetween fibers comprise apertures 172, 176 in communication with aninterior longitudinal passage.

The pulling of ends 158, 162 can cause movement of portions 180, 184relative to passage portion 168, and the loops 188, 188′ can be reducedto a desired size or placed in a desired tension. Tension in loops 188,188′ can cause the body 164 defining the passage portion 168 to beplaced in tension and therefore cause passage portion 168 to constrictabout portions 180, 184 passed therethrough. This constriction reducesthe diameter of passage portion 168, thus forming a mechanical interfacebetween the exterior surfaces of portions 180, 184 and an interiorsurface of passage portion 168. This constriction results in staticfriction between the interior and exterior surfaces at the mechanicalinterface, causing the adjustable flexible member 154 to “automatically”lock in a reduced size or diameter configuration in which tension ismaintained. Flexible member construct 150 with adjustable loops 188,188′ can be used to compress a fractured or sectioned bone, such as asectioned sternum in a sternal closure procedure following open chestsurgery, as will be discussed herein.

With additional reference to FIG. 3A, adjustable flexible memberconstruct 150 is shown having attachment members or flexible anchors 196coupled to loops 188, 188. Each loop can include various numbers ofanchors coupled thereto, including more or fewer anchors 196 than shown.Each anchor 196 can define a hollow core and can include a pair ofapertures 200, 204 formed in a body 208 thereof in a similar manner asapertures 38, 46 discussed above. Flexible member 154 can pass throughfirst aperture 204 into the hollow core and out through the secondaperture 200, as shown in FIG. 3A. Apertures 200, 204 can be placedinward from respective ends 212, 216 of anchors 196 so as to form tailportions 220, 224 adjacent each aperture 200, 204. The tail portions220, 224 can provide anchoring resistance relative to a correspondingbone or anchoring structure, as will discussed herein.

With reference to FIG. 3B and continuing reference to FIGS. 3 and 3A, analternative adjustable flexible member construct 150A is shown.Construct 150A can be formed to include a double loop configurationhaving two loops 240, 240′ that each traverse a path from one end ofpassage portion 168 to the other end thereof, instead of each loop beingdisposed at respective opposite ends of passage portion 168 as inconstruct 150. Flexible member construct 150A can be formed by passingthe first end 158 of the flexible member through aperture 176, throughpassage portion 168 and out aperture 172. The second end 162 can bepassed through aperture 172, through the passage portion 168 and out theaperture 176. In various aspects, the first and second apertures 172,176 can be formed during the braiding process as loose portions betweenpairs of fibers defining the flexible member 154, as discussed above.Passing ends 158, 162 through the apertures 172, 176 can form the loops240, 240′. The loops 240, 240′ can define mount or summit portions 244,244′ of the adjustable flexible member construct 150A and can bedisposed generally opposite from the passage portion 168. Flexiblemember construct 150A can be used, for example, to compress a fracturedor sectioned bone or to close a sectioned sternum in sternal closureprocedures, as will be discussed herein.

The longitudinal and parallel placement of the first and second ends 158and 162 of the flexible member 154 within the passage portion 168resists the reverse relative movement of the first and second portions180, 184 of the flexible member construct 150A once it is tightened. Thetensioning of the ends 158 and 162 can cause relative translation of theportions 180, 184 relative to passage portion 168. Upon applying tensionto the first and second ends 158 and 162, the loops 240, 240′ can bereduced to a desired size or placed in a desired tension. Tension in theloops 240, 240 can cause the body of the flexible member 154 definingthe passage portion 168 to be placed in tension and therefore causepassage portion 168 to constrict about the portions 180, 184 similarlyto the constriction discussed above with respect to construct 150. Thisconstriction can cause the adjustable flexible member construct 150A to“automatically” lock in a reduced size or smaller diameterconfiguration. A further discussion of the flexible member constructs150, 150A are provided in U.S. Parent Ser. No. 11/541,506 filed on Sep.29, 2006 entitled “Method and Apparatus for Forming a Self-LockingAdjustable Suture Loop” assigned to Biomet Sports Medicine, LLC, and thedisclosure is incorporated by reference.

Referring now to FIGS. 4-16, the use of flexible member constructs 10,150 and 150A in various assembly configurations and exemplary sternalclosure procedures will now be described. With particular reference toFIGS. 4 and 5, a sternum 304 is shown having a section or cut 308separating sternal portions 312, 316, such as may be performed inconnection with cardiac surgery. Flexible member constructs 10, 150,150A alone, or in various combinations with each other or additionalfixation devices, can be used to compress and secure sternal portions312, 316 together to assist healing, as will be discussed herein.

In FIGS. 4 and 5, adjustable flexible member construct 10 is shown invarious configurations to compress sternal portions 312, 316 toward eachother to close section 308. In one exemplary configuration, two flexiblemember constructs 10 can be used in a diagonal pattern in the manubrium320 of the sternum in connection with two pairs of diagonally oppositeholes 324 formed in the manubrium 320. While the diagonal pattern offlexible member construct 10 is shown in the manubrium 320 in FIG. 4, anon-diagonal or medial-lateral configuration can alternatively be used,as generally shown in FIG. 5.

To secure flexible member construct 10 to the manubrium 320, passingmember 118 can be inserted through a first hole 324 a of a respectivepair of holes 324 a, 324 b and directed towards a corresponding secondhole 324 b, as shown in FIG. 5. A surgeon or the like can pull thepassing member through the second hole 324 b thus routing at least thefixed portion 34 through the first and second holes 324 a, 324 b. Fixedportion 34 can then be secured to attachment member 80, as shown in FIG.4. Once fixed portion 34 is secured to the attachment member, first andsecond ends 18, 26 can be pulled or tensioned to reduce the loops 66, 70to a desired size and to place construct 10 in a desired tension tocompress and close the sectioned sternum 304. Ends 18, 26 of construct10 can be tensioned by pulling on the respective ends as discussedabove, or with the use of the handle 116, as generally shown in FIG. 4.Handle 116 can provide the surgeon with an ability to easily tensionends 18, 26 simultaneously and evenly. Handle 116 can then be removedand discarded. Handle 116 can be used to evenly tension loops 66, 70 asdiscussed above, or can be used to tension loops 66, 70 at differentrates by manipulating an angle of handle 116 so that, for example, afirst loop of loops 66, 70 can be tensioned at a faster rate than asecond loop of loops 66, 70. In this manner, the first loop can reach adesired final tension before the second loop. In one exemplaryconfiguration, the smaller diameter flexible member can be used withconstruct 10 in manubrium 320 for easier manipulation through holes 324.

Flexible member construct 10 can also be used to compress a body 332 ofsternum 304, as also shown in FIGS. 4 and 5. For the body 332, construct10 can be wrapped around the sternum and fixed portion 34 can be securedto attachment member 80 such that ends 18, 26 extend from an anteriorside 336 of body 332, as shown in FIG. 4. In the exemplary configurationshown in FIG. 4, three flexible member constructs 10 are shown securingthe body 332 of the sternum 304. Nevertheless, more or fewer flexibleconstructs than shown can be used in the intercostal spaces between theribs to secure the body of the sternum, as may be determined by asurgeon during a sternal closure procedure. In addition, the largerdiameter flexible member construct 10 can be utilized in body area 332of sternum 304, according to one exemplary configuration. The largerdiameter flexible member can enable more tension to be applied to thebone or sternum without cutting into or damaging the bone.

The flexible member constructs 10 can be attached and tensioned orsecured to the sternum 304 in various orders. For example, flexiblemember constructs 10 can first be attached to the manubrium 320 and thento the body 332, or vice-versa. Additionally, flexible member constructs10 can be tensioned in various orders, such as initially tensioning eachflexible member construct 10 to a snug or non-slack condition and thenfurther tensioning each construct 10 to a final desired tension. Asdiscussed above, constructs 10 can be tightened with or without use ofhandle 116. Flexible construct 10 can automatically lock under tension,as also discussed above, after which a portion of ends 18, 26 can betrimmed and removed.

Flexible member construct 10 also can be provided with an antibioticand/or platelet concentrate coating to resist bacterial adhesion and/orpromote healing. In this regard, flexible member construct 10, as wellas other constructs discussed herein, can be pre-configured with such acoating or the coating can be applied intraoperatively. Further, thesurgeon can also apply the platelet coating to the sectioned area duringthe sternal closure procedure.

With additional reference to FIGS. 6 and 10, flexible member construct150A is shown in an assembly configuration 350 having a pair ofattachment members 354 coupled to opposed sides 356 of loops 240 and240′. Attachment members 354 can include a generally arcuate shape 358and, in the exemplary configuration shown in FIG. 6, a generallysemicircular shape or U-shape. The shape 358 of attachment members 354can be used to secure the attachment members 354 to medial and lateralsides 362 of sternum 304, as generally shown in FIG. 10. Attachmentmembers 354 can include an aperture 366 for receiving loops 240, 240′therethrough, as shown in FIG. 6. In an exemplary configuration,flexible member construct 150A can be formed integrally with attachmentmembers 354 for use in a sternal closure or other fracture reductionprocedure. In this manner, attachment members 354 can be preformed andcoupled to loops 240, 240′ to form assembly configuration 350, which canbe provided in the assembly configuration for use in the sternal closureprocedure.

With particular reference to FIG. 10, construct 150A in the assemblyconfiguration 350 can be used to compress the sternum 304 by securingattachment members 354 to the sides 362 of sternal portions 312, 316 andthen applying tension to ends 158, 162 of construct 150A. The adjustableloops of construct 150A can then be reduced to the desired size andplaced in the desired tension to compress sternum 304 about section 308.Flexible member construct 150A can automatically lock under tension tomaintain the reduced size of loops 240, 240′, as discussed above. Itshould be appreciated that while attachment members 354 are describedabove in connection with flexible member construct 150A, the attachmentmembers 354 can also be used with alternative flexible memberconstructs, such as construct 150.

Turning now to FIG. 7 and with reference to FIG. 10, flexible memberconstruct 150 is shown in an assembly configuration 376 operativelyassociated with an attachment member or frame 380. Frame 380 can be usedto facilitate securing flexible member construct 150 around a fracturedbone or the sectioned sternum 304 to compress the fracture or sectionand affect healing. Frame 380 can include a pair of attachment portions384 at opposed ends 388 of the frame. In the exemplary configurationshown, frame 380 can include a generally rectangular plate 392 and theattachment portions 384 can be in the form of V-shaped aperturesextending through plate 392 from a top surface 396 to a bottom surface400, as shown in FIG. 7. Bottom surface 400 can optionally include apair of fixation members 404 to prevent movement of frame 380 relativeto the sternum 304 upon placement thereon. Fixation members 404 caninclude spikes, posts, screws, adhesive or the like that are coupled toor pass through or extend from the bottom surface 400.

With additional reference to FIG. 10, flexible member construct 150 inthe assembly configuration 376 is shown with the bottom surface of frame380 positioned on the anterior side 336 of sternum 304. Flexible memberconstruct 150 can then be wrapped around sternum 304 and opposed ends412 of loops 188, 188′ can be secured to frame 380 via attachmentportions 384. In this configuration, passage portion 168 can bepositioned on a posterior side of sternum 304, as generally shown inFIG. 10. Ends 158, 162 of construct 150 can then be tensioned to reducethe loops 188, 188′ to the desired size and tension to compress andclose section 308 and assist healing of sternum 304. Flexible memberconstruct 150 can automatically lock and maintain the reduced size ofloops 188, 188′ under tension, as discussed above. It should beappreciated that frame 80 can also be used with flexible memberconstruct 10.

Referring now to FIGS. 8 and 10, flexible member construct 150 is shownin an assembly configuration 420 operatively associated with anattachment member or frame 430. Frame 430 can include a base 434, a post438 extending from an upper surface 442 of base 434, and at least oneoptional fixation member 446 extending from a lower surface 448 of base434. Fixation member 446 can include spikes, posts, screws, adhesive orthe like that are coupled to or extend from lower surface 448. Post 438can include a reduced diameter neck portion 450 coupled to the base anda larger diameter or head portion 454 coupled to the neck portion 450and configured to retain loops 188, 188′ of construct 150, as discussedbelow. Frame 430 can be placed on sternum 304 with lower surface 448engaging the anterior side 336 of sternum 304, as shown in FIG. 10.Flexible member construct 150 can be wrapped around sternum 304 in oneof the intercostal spaces and each loop 188, 188′ can be secured to theframe 380 via post 438, as also shown in FIG. 10.

In this exemplary configuration, passage portion 168 can be positionedon the posterior side of sternum 304. Once frame 430 is positioned andconstruct 150 is wrapped around the sternum and secured to post 438,ends 158 and 162 extending from the posterior side of sternum 304 can betensioned. Applying tension to ends 158, 162 can reduce loops 188, 188′to a desired size and tension to compress sectioned sternal portions312, 316 together to assist healing at section 308, as generally shownin FIG. 10. Flexible construct 150 can automatically lock loops 188,188′ under tension to maintain the reduced size of loops 188, 188 andcompression of sternal portions 312, 316 together, as discussed above.

It should be appreciated that while reference to FIG. 10 has been madewith respect to the assembly configurations 350, 376 and 420, theseassembly configurations have been combined in one figure forillustration purposes only and need not be used together. In thisregard, an exemplary sternal closure procedure could utilize only one ofthe assemblies shown in the intercostal spaces, or combinations thereof,as may be desired by a particular surgeon performing a sternal closureprocedure. It should also be appreciated that assemblies 350, 376 and420 could be used individually or in various combinations with flexiblemember constructs 10 secured to the manubrium 320, as discussed abovewith reference to FIG. 4.

Referring now to FIGS. 9 and 11, adjustable flexible member construct150 is shown in an assembly configuration 468 operatively associatedwith a frame 472. As shown in FIG. 9, frame 472 can include a generallyrectangular body 476 with attachment portions 480 positioned at one pairof diagonally opposed corners 484 and a groove or channel 486 extendingdiagonally across a top surface of frame 472 from a second pair ofopposed corners 488. While frame 472 is shown having rectangular body476, it should be appreciated that frame 472 can be configured in othershapes, such as various polygonal shapes for use in coupling frame 472to flexible member construct 150, as will be described below. Attachmentportions 480 can each include a recess 492 at least partiallysurrounding a post 496. Post 496 can include a neck portion 500 and acap or head portion 504 having a width dimension 508 greater than acorresponding width of neck portion 500 such that at least a portion ofhead portion 504 overhangs neck portion 500, as shown in FIG. 9. Atleast one optional fixation member 512 can extend from a bottom surface516 of frame 472.

With particular reference to FIG. 11, frame 472 can be positioned invarious configurations relative to sternum 304, as illustrated by thetwo exemplary configurations shown in FIG. 11. Frame 472 can bepositioned on sternum 304 such that the bottom surface 516 engages theanterior side 336 of sternum 304. Flexible member construct 150 can bewrapped around sternum 304 within an intercostal space thereof and loops188, 188′ can be coupled to respective attachment portions 480. Morespecifically, flexible construct 150 can be placed in channel 486 suchthat passage portion 168 is positioned within channel 486, as shown inFIG. 11. Positioning construct 150 in channel 486 can provide a lowprofile closure arrangement that can be more conformable or provide lessdiscomfort to a recipient patient. Loop portion 188 can then be wrappedaround the posterior side of sternum 304 in one direction and coupled toattachment portion 480A of the pair of attachment portions 480.Similarly, loop portion 188′ can be wrapped around the posterior side ofsternum 304 in an opposite direction of loop 188 and then be coupled toattachment portion 480B. Tension can then be applied to ends 158, 162 toreduce the size of loops 188, 188′ to compress sternal portions 312, 316together to assist healing of sectioned sternum 304 at section 308.Flexible member construct 150 can automatically lock loops 188, 188′ atthe desired reduced size under tension, as discussed above. In addition,placing frame 472 over the section can also stabilize the sternum toalign sternal portions 312, 316 to be co-planar.

Flexible member construct 150 in the assembly configuration 468 can beused alone or in various combinations with flexible member constructs 10and 150A and/or assembly configurations 350, 376 and 420 discussedabove. For example, flexible member constructs 10 can be used in themanubrium 320 as shown in FIG. 4 and assembly 468 can be used alone orin various combinations with assemblies 350, 376 and 420 in the body 332to compress sternal portions 312, 316, as discussed above.

Referring now to FIG. 12, adjustable flexible member construct 150 isshown operatively associated with anchors 196 and an orthopedic mesh 550for use in a sternal closure procedure. More particularly, orthopedicmesh 550 can be positioned on the anterior side 336 of sternum 304 suchthat portions 554 extend around the lateral sides 362 in the intercostalspaces, as shown in FIG. 12. The orthopedic mesh 550 can be, forexample, a product sold by Biomet Sports Medicine, LLC under the nameSportMesh™. With the orthopedic mesh 550 positioned on sternum 304 asdiscussed above, construct 150 with anchors 196 can be used in variousconfigurations to compress the sectioned sternum 304 at section 308, asgenerally shown in FIG. 12.

The orthopedic mesh 550 can be coated with the platelet concentratediscussed above, and/or antibiotics, bone growth agents, etc. to aid insoft tissue healing. The mesh 550 can provide a barrier between theflexible member constructs and the bone to aid in transferring load fromthe flexible member construct to the mesh 550, which can decrease thepressure applied to the bone by the tensioned flexible member construct.The mesh 550 can be particularly useful, for example, in patients withsoft bone tissue. It should also be appreciated that load distributionin the intercostal spaces can be provided by the portions 554 thatextend around the medial and lateral sides. Moreover, the orthopedicmesh can aid in the retention of anchors 196, particularly where thebone tissue may be soft.

In one exemplary configuration, four holes 558 can be formed through themesh 550 and the manubrium 320. Flexible anchors 196 associated with twoflexible member constructs 150 can be inserted through respectivediagonal pairs of holes 558 through the manubrium, as shown in FIG. 12.The constructs 150 can be in diagonal overlapping pattern and bedisposed primarily on top of the orthopedic mesh 550. Upon tensioningthe free ends 158, 162 of each construct 150, the tail portions 220, 224of anchors 196 can engage the posterior manubrium adjacent holes 558 andprovide anchoring resistance to retain the anchors 196 outside of holes558 on the posterior side of the sternum 304. The loops 188, 188′subsequently can be reduced to the desired size or tension to compresssternal portions 312, 316 and assist closure and healing of thesectioned sternum. The orthopedic mesh 550 can work to distribute theload placed on the anterior side 336 of the sternum by the constructs150 under tension. A similar configuration 562 can be used at a lowerportion 566 of the sternum 304 adjacent the Xiphoid process, as alsoshown in FIG. 12. It should be appreciated that configuration 562, aswell as the configuration discussed immediately above with respect tothe manubrium, can alternatively be in a parallel transverse pattern asopposed to the illustrated diagonal patterns.

Continuing with FIG. 12, adjustable flexible construct 150 having a pairof anchors 196 attached to respective loops 188, 188′ can be insertedthrough transverse bores 586 formed in sternum 304. In particular, theconstructs 150 can be positioned in bores 586 such that the passageportions 168 are each aligned in a respective bore 586, as shown in FIG.12. The constructs 150 can be pierced or routed through the portions 554of orthopedic mesh 550 that extend around the lateral sides of sternum304 so as to provide additional anchoring resistance and loaddistribution for flexible anchors 196, as shown in FIG. 12. Ends 158,162 can be tensioned to compress sternal portions 312, 316, as discussedherein. It should be appreciated that while orthopedic mesh 550 is shownin FIG. 12 with reference to construct 150 and flexible anchors 196,orthopedic mesh 550 can be used in various other sternal closureconfigurations disclosed herein, for example, to distribute a loadapplied by the various disclosed flexible member constructs relative tothe sternum 304.

Referring now to FIGS. 13 and 14, adjustable flexible member construct150 is shown in exemplary assembly configurations 600 and 604operatively associated with attachment members 608. Each attachmentmember 608 can include a body 612 having a substantially U-shapedconfiguration and can be sized for positioning about the lateral sides362 of sternum 304 such that top and bottom portions 616, 620 extendabout the respective anterior and posterior sides of the sternum, asshown in FIG. 14. In one exemplary configuration, attachment member 608can include an aperture 624 positioned within a side portion 628connecting the top and bottom portions 616, 620. In anotherconfiguration, attachment member 608 can include an aperture 632 in thetop portion 616, as shown in FIG. 14. Aperture 632 can be in lieu of orin addition to aperture 624.

With reference to assembly configuration 600, flexible member construct150 with anchors 196 can be positioned through transverse bore 636 insternum 304 such that passage portion 168 is positioned within the bore.Each respective loop 188, 188′ with anchors 196 can be passed throughaperture 624 in attachment member 608 such that the anchors 196 are on afirst side of portion 628 opposite a second side adjacent the sternum304. Ends 158, 162 can then be tensioned thereby reducing a size ofloops 188, 188′ so as to draw attachment members 608 against the lateralsides of sternum 304 and compress sternal portions 312, 316 together.Flexible member construct 150 can automatically lock the loops in thereduced diameter configuration under tension, as described herein.Attachment members 608 can facilitate distributing a compression loadapplied to the sternum by the tensioned construct 150, which can enablemore tension to be applied.

With continuing reference to FIG. 14, assembly configuration 604 caninclude attachment members 608 integrally formed or pre-assembled withflexible member construct 150A such that loops 240, 240′ are coupled toapertures 632. In this configuration, attachment members 608 can bepositioned against the respective lateral sides of sternum 304, similarto assembly configuration 600 discussed above. Flexible member construct150A can be positioned relative to the anterior side 336 of sternum 304such that it does not wrap around or extend through sternum 304. Itshould be appreciated that assembly configurations 600, 604 can be usedalone or with various other flexible member construct and assemblyconfigurations disclosed herein to compress sternal portions 312, 316 toassist healing of sectioned sternum 304.

Turning now to FIG. 15, an alternative configuration 650 for compressionof sternum 304 in a sternal closure procedure is provided. Configuration650 can include two flexible member constructs 10 in a transverseorientation in the manubrium 320, as generally discussed above withreference to FIGS. 4 and 5. Configuration 650 can also include flexiblemember construct 150A coupled around the two constructs 10 before fixedportion 34 of each construct 10 is coupled to the respective attachmentmember 80, as shown in FIG. 15. Construct 150A can be positionedgenerally in a superior-inferior orientation perpendicular to thetransverse orientation of constructs 10. Construct 150A can be tensionedafter tensioning constructs 10 to draw any remaining tension from thesystem. In this configuration, constructs 10 can providecross-tensioning generally perpendicular to section 308 and construct150A can provide tensioning generally parallel to section 308.Configuration 650 can also be utilized to compress the body 332 ofsternum 304, where constructs 10 are wrapped around the sternum 304instead of through holes 324, as also shown in FIG. 15.

Referring now to FIG. 16, another alternative configuration 670 forcompression of sternum 304 in a sternal closure procedure is provided.Configuration 670 can include two separate continuous suture or flexiblemember loops 674 having a fixed length. Alternatively, a flexible memberconstruct, such as construct 150, can be used in place of fixed loops674 to provide additional adjustment and tensioning capability. Flexiblemember construct 150A can be provided with four attachment members 80integrally coupled to loops 240, 240′. In the manubrium area, loops 674can be routed or passed along the posterior side of sternum 304 in atransverse orientation such that opposed ends 678 of loops 674 extendthrough a respective pair of holes 324, as shown in FIG. 16. The opposedends 678 of each of loops 674 can be coupled to a respective two of thefour attachment members 80. The ends 158, 162 of flexible memberconstruct 150A can then be tensioned to compress sternal portions 312,316, as discussed herein. Additional configurations 670 can be used tocompress body 332 of sternum 304 where the fixed loops are wrappedaround the sides of sternum 304 as opposed to being passed through holes324, as also shown in FIG. 16. It should be appreciated thatconfigurations 650 and 670 can be used alone or with variouscombinations of the flexible member constructs and assemblyconfigurations discussed herein.

While one or more specific examples have been described and illustrated,it will be understood by those skilled in the art that various changesmay be made and equivalence may be substituted for elements thereofwithout departing from the scope of the present teachings as defined inthe claims. Furthermore, the mixing and matching of features, elementsand/or functions between various examples may be expressly contemplatedherein so that one skilled in the art would appreciate from the presentteachings that features, elements and/or functions of one example may beincorporated into another example as appropriate, unless describedotherwise above. Moreover, many modifications may be made to adapt aparticular situation or material to the present teachings withoutdeparting from the essential scope thereof.

What is claimed is:
 1. A method of compressing a separated sternum in apatient, comprising: providing or obtaining an adjustable sutureconstruct that includes a suture with a first free end that extends intothe suture through a first aperture in the suture, longitudinally withinthe suture along a first longitudinal passage, and out of the suturethrough a fourth aperture in the suture to form a first adjustable loop;connecting a first portion of the adjustable suture construct to asecond portion of the adjustable suture construct to thereby encircle atleast a portion of a separated sternum in a patient; and pulling on thefirst free end of the suture following said connecting so as to reduce asize of the first adjustable loop and thereby compress the separatedsternum.
 2. The method of claim 1, wherein said connecting includesconnecting the first portion of the adjustable suture construct to thesecond portion of the adjustable suture construct with an attachmentmember.
 3. The method of claim 1, wherein the adjustable sutureconstruct is free of knots.
 4. The method of claim 1, wherein the firstportion of the adjustable suture construct is located along the firstadjustable loop.
 5. The method of claim 1, wherein the suture includes asecond free end that extends into the suture through a second aperturein the suture, longitudinally within the suture along a secondlongitudinal passage, and out of the suture through a third aperture inthe suture to form a second adjustable loop.
 6. The method of claim 5,wherein the second portion of the adjustable suture construct is locatedalong a fixed-length portion of the adjustable suture construct that islocated between the first longitudinal passage and the secondlongitudinal passage.
 7. A method of compressing a separated sternum ina patient, comprising: encircling at least a portion of a separatedsternum in a patient with an adjustable suture construct, the adjustablesuture construct including a suture with a first free end and a secondfree end, the first free end extending into the suture through a firstaperture in the suture, longitudinally within the suture between thefirst aperture and a fourth aperture in the suture, and out of thesuture through the fourth aperture to form a first adjustable loop, thesecond free end extending into the suture through a second aperture inthe suture, longitudinally within the suture between the second apertureand a third aperture in the suture, and out of the suture through thethird aperture to form a second adjustable loop; and pulling on thefirst free end and the second free end of the suture following saidencircling so as to reduce a size of the first adjustable loop and asize of the second adjustable loop, respectively, to thereby compressthe separated sternum.
 8. The method of claim 7, wherein the sutureextends along a first longitudinal passage in the suture between thefirst aperture and the fourth aperture and along a second longitudinalpassage in the suture between the second aperture and the thirdaperture.
 9. The method of claim 8, wherein the suture includes afixed-length portion that is located between the first longitudinalpassage and the second longitudinal passage.
 10. The method of claim 9,wherein said encircling includes connecting the fixed-length portion tothe first adjustable loop.
 11. The method of claim 10, wherein thefixed-length portion is connected to the first adjustable loop and thesecond adjustable loop with an attachment member.
 12. The method ofclaim 7, wherein the adjustable suture construct is free of knots. 13.The method of claim 7, wherein the separated sternum is a fracturedsternum.
 14. A method of compressing a separated sternum in a patient,comprising: providing or obtaining an adjustable suture construct thatincludes a suture with a first free end that extends longitudinallythrough a first longitudinal passage in the suture to form a firstadjustable loop, the adjustable suture construct further including anattachment member coupled to a first portion of the adjustable sutureconstruct; coupling the attachment member to a second portion of theadjustable suture construct to thereby encircle at least a portion of aseparated sternum in a patient; and pulling on the first free end of thesuture following said coupling so as to reduce a size of the firstadjustable loop and thereby compress the separated sternum.
 15. Themethod of claim 14, wherein the adjustable suture construct is free ofknots.
 16. The method of claim 14, wherein the first portion of theadjustable suture construct extends through an aperture in theattachment member.
 17. The method of claim 14, wherein the first portionof the adjustable suture construct is located along the first adjustableloop.
 18. The method of claim 14, wherein the suture includes a secondfree end that extends longitudinally through a second longitudinalpassage in the suture to form a second adjustable loop, the first freeend extending longitudinally through the first longitudinal passagewithout extending through the second longitudinal passage, the secondfree end extending longitudinally through the second longitudinalpassage without extending through the first longitudinal passage. 19.The method of claim 18, wherein the second portion of the adjustablesuture construct is located along a fixed-length portion of theadjustable suture construct that is located between the firstlongitudinal passage and the second longitudinal passage.